Pentagon Conducting Research Into Adverse Effects of Anthrax Vaccine While Maintaining it is Safe

Pentagon conducting research into adverse effects of anthrax vaccine while maintaining it is safeJulie Weisberg

Volunteers for study to be questioned for eight yearsThe Pentagon resumed its controversial mandatory anthrax vaccinations program for selected troops last week despite the fact that its own doctors are quietly conducting research into adverse effects of the vaccine, a RAWSTORY investigation has found.

While the Defense Department maintains that the anthrax vaccine is safe and poses no long-term risks to recipients, a little-known program at WalterReed - the National Vaccine Healthcare Center - seems to contradict the military's assertions.

Documents obtained by RAW STORY, including a participant' s agreement, case history and government documents, show that military medical personnel have known since at least 1998 that there are genetic triggers between illnesses and some required immunizations, including the anthrax vaccine. They also reveal the military knew and did not implement routine pre-screening which could help reduce vaccine-related illnesses.

A flyer posted by the Vaccine Healthcare Center shows that Walter Reed is soliciting servicemembers who have suffered as a result of the vaccine. The flyer asserts that "adverse effects may include redness or swelling where the shot was given (larger than the bottom of a soda can) and/or more than 24 hours of headaches, muscle/joint pains, and/or fatigue (tiredness) that interfered with your daily activities."

"Only one visit and only one blood draw is required," the flyer says. "You will also receive annual e-mail or telephone follow-up surveys for eightyears." (Click on the image to enlarge.)

US Army Medical Command Media Relations Officer Margaret Tippy made several efforts to put RAW STORY in touch with Vaccine Healthcare Center officials over the past several weeks. Defense medical officials, however, did not returned repeated request for information about the VHC program.

In 2004, a federal judge ruled that the military's mandatory administration of the vaccine was illegal because the Food and Drug Administration had not approved its use for inhalation anthrax, only for anthrax contracted through the skin. After FDA approval, the judge allowed voluntary injections. The Defense Department resumed mandatory shots this month. The Pentagon continues to defend the efficacy and safety of the vaccine.

"I'll say once again, the vaccine is safe and effective," Assistant Secretary of Defense for Health Affairs William Winkenwerder said last year.

Longstanding concerns

Doctors have raised questions about the vaccine for years. According to a transcript of an Apr. 16, 1998 meeting of the Armed Forces Epidemiological Board, military experts concluded that pre-vaccination screenings could be conducted because the military has "the technological and data capture capability" to do so, and that they should be done because "we're dealing with this problem with anthrax now and many other immunizations. " "There is going to be more in the future," the transcript added.

The existence of the Vaccine Healthcare Center complicates the mystery surrounding vaccine-related illnesses, suggesting either that pre-screening is not part of the vaccination process or that genetic triggers are not the only cause of vaccine related health effects.

Created in 2001 as a joint effort of the Centers for Disease Control and the Department of Defense, the VHC program and its network of treatment and research facilities are largely unknown even among the military community.

Walter Reed Medical Center serves as the headquarters of the program, which also includes clinics at Fort Bragg, Lackland Air Force Base and Portsmouth Naval Medical Center.

Since its inception, the treatment component of the program has helped hundreds of soldiers suffering serious and sometimes debilitating side-effects from anthrax and other vaccinations to get the proper military medical treatment, vaccine exemptions and case management that they would not have access to otherwise. Many anti-vaccination advocates question why the VHC treatment program is not more widely publicized and why the VHC's research is not available to medical professionals and the public.

Dr. Meryl Nass, an anthrax expert and physician who has treated soldiers suffering from adverse reactions to the anthrax vaccine, believes the VHC's research findings should be released. "I knew they were doing this kind of research, but they just wouldn't admit it," Dr. Nass said in a phone interview last week. "VHC has been conducting this type of research, but they haven't been publishing any of it. This could save more people from becoming ill."

Luis Hernandez's mystery lesion

Luis Hernandez, a recently-retired Navy reservist, is a current participant in the VHC study. Hernandez says he was approached last September by VHC researchers to take part during a routine visit to Walter Reed relating to his disability claim. (His affidavit for the program is available here. The sections of his file describing his symptoms and their impact on his quality of life are here.)

An Iraq War veteran who served in the US military for 25 years, the 51-year-old New Yorker received his first series of anthrax vaccinations when he was mobilizing for deployment in February 2003, a month before Operation Iraqi Freedom began.

A few days after receiving his third anthrax vaccination, Hernandez says, he developed a lesion on his leg that he was told was most likely a spider bite. He was put on a course of antibiotics and continued preparing for deployment.

"I had never had health problems," he said. The lesion grew and other autoimmune problems developed. In May 2006, Hernandez was forced to return home to receive medical care. "When I got back, I had 13 lesions," he said. "It was just too much for my immune system," he said of the vaccine. "They didn't know what the hell I had."

When he told the military he thought that his illness was related to the vaccine, he said, staff told him he was "delusional" and the relation between his mystery autoimmune illness and the shots "were in his head."

"For a while," he said, "I thought I was going crazy." A private physician who had been attending to Hernandez's case referred him to Walter Reed's Vaccine Healthcare Center to seek additional tests in hopes of diagnosing the "mystery illness." Hernandez said no one in the military had ever told him of the program's existence.

According to Hernandez's medical documents, the reservist was suffering from muscle spasms, headaches, recurring skin lesions, chronic fatigue and depression when he first visited Walter Reed in January 2004. "Hernandez' life has been profoundly effected [sic] by his clinical symptoms," VHC staff wrote. "He is in constant pain, has difficulty functioning at his civilian job and has used 400 hours of civilian sick leave." RAW STORY will post excerpts from Hernandez's documents later today. "We have noted in a number of service members who now exhibit chronic, refractory headaches as well as persistent musculoskeletal pain in temporal association with the receipt of the anthrax vaccine," VHC staff added. "Based on these observations, we are attempting to establish case definitions as well as diagnostic, treatment and vaccination options."

"When I got down there, they told me, 'we know what you got, but we can't fix you,'" he said of VHC staff. "They said they had seen other servicemembers with the same symptoms." Hernandez is now asking the same question many vaccinated soldiers already have: Is the vaccine safe? Did the military know the vaccine could cause health problems? "The D.O.D. is telling us that the vaccine is safe, and yet they are conducting this multi-million dollar research project," he said. "It is too late for me, but the military is just going to pump these kids' bodies full of this stuff."

Dr. Nass, who practices medicine in Maine, believes the vaccine is unsafe and is responsible for a host of illnesses in U.S. troops.

"There are so many people who are damaged by this vaccine," she remarked. "Its use makes no sense."

The numbers of soldiers who have become ill as a result of the anthrax vaccine is largely unknown, primarily because conditions may not be not either properly diagnosed or recorded, and because many military studies are not available to health care professionals or the public.

In 2003, 22-year-old Army Reservist Specialist Rachel Lacy died shortly after receiving her first batch of vaccines. According to a military medical panel, the evidence surrounding Lacy's death "favored a causal relationship," but the panel decided that the "evidence was not conclusive."

The cause of death was described as "a severe inflammatory process affecting her lungs, findings consistent with a diagnosis of systemic lupus erythematosus (SLE) or lupus."

Manufacturer says studies show product is safe

Created by Emergent BioSolutions (formerly Bioport), the anthrax vaccine is known as BioThrax or Anthrax Vaccine Absorbed and was first licensed by theFood and Drug Administration in 1970. It remains the only FDA-approved anthrax vaccine for use in the US.

In an interview with RAW STORY, Emergent Biosolutions spokesperson Dr. Tom Waytes said the anthrax vaccine has been studied more than just about any vaccine in the US and has been deemed safe and effective. He said the vaccine has no higher adverse reaction rate than most other vaccines. A recent report issued by the military reviewing the vaccine's safety, as well as a 2002 report issued by the Institute of Medicine, he added, have also backed the vaccine.

In the Institute of Medicine's report - which reviewed existing studies on the vaccine's safety and effectiveness - the committee found that "the available evidence shows that the currently licensed anthrax vaccine, Anthrax Vaccine Adsorbed (AVA), is reasonably safe and effective, with the caveat that the studies reviewed were carried out in populations of healthy adults only." The IOM report also pointed out that "although the committee found no data indicating that vaccination with AVA is associated with later-onset adverse events or with any serious or lasting adverse events," few, if any, studies had been done regarding the vaccine's long term safety." DoD should carefully evaluate options for longer-term follow-up of the possible health effects of vaccination against anthrax (and other service-related exposures)," committee members urged in their report.

Last May, the Government Accountability Office (GAO) issued a report that called for "a better, alternative vaccine."In the May 2006 report, the GAO said the "vaccine has not been adequately tested on humans; no studies have been done to determine the optimum number of doses; the long-term safety has not been studied and data on short-term reactions are limited."

Dr. Waytes asserted that the majority of soldiers' claims that the vaccine causes autoimmune disorders and serious illnesses are "in people's minds."

Late last year, another group of anonymous soldiers and civilians filed a new lawsuit to stop the resumption of the mandatory program. The Pentagon has filed a motion to dismiss the case, according to one of the lead lawyers for the plaintiffs, retired Air Force Lt. Col. John Michels.

"This whole thing just has this bureaucratic momentum," Michels said.

Larisa Alexandrovna and Muriel Kane contributed research to this report.

Anthrax Vaccinations for Soldiers are Not Mandatory Elsewhere, and Few International Soldiers Choose Vaccination (Editorial)

Anthrax vaccinations for soldiers are not mandatory elsewhere, and few international soldiers choose vaccinationMeryl Nass, MD

In 1998, when mandatory vaccinations began in the United States, Canada and the United Kingdome also began vaccinations. Canada’s vaccinations were mandatory—but not for long (see below). It had always been policy in the UK to give voluntary vaccinations to soldiers, and anthrax vaccine was no exception.

United Kingdom British authorities have claimed that 50% of troops accepted the vaccine voluntarily. [1] However, the only two published studies, both conducted by military researchers, to look at vaccine acceptance in the UK military indicated that fewer than 50% accepted the vaccine. In the first paper,[2] 129 soldiers working in a military field hospital were offered vaccine; 76% (98 soldiers) accepted and began the series. Initially 63% had adverse reactions, and the authors noted, “forty-five percent of these caused incapacity.” Approximately 22% of reactors had arm pain that prevented lifting or driving for 48 hours. Twenty-one percent of reactions were designated severe. Only 21% of the soldiers offered vaccinations completed the four dose series. The authors concluded, “Although the old vaccine is considered safe, the number of adverse reactions and incapacity reported by a military medical unit was unexpected.”

The second paper looked at vaccine acceptance and adverse reactions in personnel at five Royal Air Force bases.[3] According to the study, “Those completing the [vaccine] course as a percentage of those starting it varied from 22% at base 2 to 3.7% at base 4.” Yet the authors reported that only 11% of vaccinees had side effects, which were mild. Neither set of authors analyzed the drop-off in vaccine uptake, but it seems obvious that the vast majority of soldiers either had adverse reactions or saw others with severe enough reactions that they chose to stop the vaccinations before they were considered ‘fully vaccinated.’

In 2004, The Parliamentary Under-Secretary of State, Ministry of Defence (Lord Bach), acknowledged to a question in Parliament: “No studies of the efficacy of United Kingdom anthrax vaccine against inhalation anthrax have been undertaken in humans.” [4]

The same is true for the US vaccine; therefore, no one knows how effective either will be in the event of an attack.

British sailors were said to have thrown anthrax vaccine overboard from military vessels leaving for the Gulf in 2003. Nearly 500 vials of vaccine were found washed up on shore.[5]

Canada

In Canada in 1998, one brave airman, Michael Kipling, who felt he had been made ill by the vaccine when he received it during the Gulf War, refused the mandatory vaccination. Kipling’s refusal garnered national publicity, and the military subjected him to court martial. Canada seems to have a fairer system of military justice than the US. Kipling had extensive pre-trial proceedings in 2000, overseen by Canada’s highest military judge, Guy Brais. At the conclusion of these proceedings, Judge Brais found that Kipling could not be compelled to accept a dangerous vaccine: “It was sufficient and the court is satisfied on the balance of probabilities that the defense has successfully demonstrated that the anthrax vaccine contained in lot 020 was unsafe and hazardous and could be responsible for the important symptoms reported by so many persons who received that vaccine.

In those circumstances, the court concludes that the accused's right to life, liberty and security of the person in section 7 of the Charter of Rights and Freedoms were infringed. And as the court stated earlier, the government, through its Department of National Defense and the Canadian Forces, could never be justified to impose inoculation of soldiers with an unsafe and dangerous vaccine as a limit of their rights under section 7.”[6]

Since 2000, there have been no mandatory anthrax vaccinations in Canada. Given the ruling above, it is unlikely they will ever return. Since the Afghanistan war began in 2002, Canadian troops have not even been offered voluntary anthrax vaccinations. [7]

One Canadian military study of medical charts of vaccinated and unvaccinated soldiers concluded that vaccinated soldiers had fewer medical problems recorded by military medical facilities than unvaccinated soldiers.[8] Of 571 vaccine recipients’ charts selected for review, 165 charts could not be obtained, including 27 charts “required for current treatment.” Although the “study suggests that anthrax vaccination did not cause adverse health effects in Canadian Forces members up to 8 months after deployment,” because service members under active medical treatment were dropped from the study, its validity is questionable. Furthermore, a GAO study done for Congress of US aircrew found that 60% who became ill following anthrax vaccinations chose to seek treatment outside military medical facilities, to assure the privacy of their medical concerns and maintain their ability to continue flying.[9]

Australia

Australian troops have also been given voluntary vaccinations. However, troops felt they had been misled by their leaders regarding vaccinations on several occasions. First, information on severe reactions seen in earlier troops who received vaccine was withheld from troops receiving vaccine later.[10] [11] Second, troops were sent by ship toward the Gulf in 2003, but only when they were far from home were they told they would be receiving anthrax vaccinations. Although the vaccine was ‘voluntary’ they were told they would not be deployable if they refused, they would have to be flown home, and a refusal would have adverse effects on their future military careers.[12] This also led to much adverse publicity in Australia.[13]

The Australian Medical Association had concerns about the vaccine as well: “The Australian Medical Association has called upon the military to prove the vaccination is safe. ‘If they have that data, the medical profession in Australia would very much like to see it,’ the Association' s president Kerryn Phelps told Australian Broadcasting Corporation radio.” [14]

France

France never vaccinated Gulf War soldiers for anthrax, nor has it been used in France since the first Gulf War. France has a much smaller percentage of chronic illness in its Gulf War veterans than any of the countries mentioned above, which did vaccinate some of their troops. [15]

World Health Organization

According to the WHO: “There is a vaccine against anthrax, but it is not approved for widespread use because it has never been comprehensively tested in human trials. The vaccine is sometimes given to people who are likely to be exposed to anthrax through their occupation, for example, tannery workers, or to military personnel. It is not widely available, nor is its use for mass immunization recommended.” [16]

The Gaithersburg company makes the only federally licensed anthrax vaccine. It sells the vaccine to the Defense Department to inoculate soldiers, and in the past two years the government has purchased 10 million doses for the strategic national stockpile in case of another attack.

The problem is that federal health officials want 75 million doses for the stockpile, but they want those doses to be made using a newer generation of vaccine technology that requires just a few shots to produce immunity. That has left Emergent's vaccine, which currently requires up to six doses, mostly on the sidelines.

And it has left the government without a major supplier for the stockpile.

Emergent is trying to solve this problem by taking its vaccine, which has been around since 1970, and strapping on newer technology. The company recently cut a licensing deal with Coley Pharmaceutical Group to use its VaxImmune -- an adjuvant, or additive, that can enhance and speed up a vaccine's ability to boost immune response in the body. In some ways this is like putting new wheels on an older car in hopes that it will go faster.

"We think we can position this as a true next-generation product," said Fuad El-Hibri, Emergent's chief executive.

The company said it had some evidence that the combined technology could provide immunity with fewer shots. A study carried out by Emergent and Coley and funded by the Defense Advanced Research Projects Agency showed that people who received the combination vaccine developed peak concentrations of key antibodies 6.3 times higher than those who received the vaccine alone, and the peak was reached 21 days sooner.

Gene Mack, an analyst with HSBC Securities, which has done banking business with Emergent, said using the adjuvant technology, rather than developing a whole new vaccine, "is a way to meet the government in the middle" and give federal health officials what they want.

The question is: Will it be enough? Emergent faces some major hurdles in dealing with the Department of Health and Human Services, which sought the new generation of anthrax vaccines under the $5.6 billion Project BioShield program. In November 2004, HHS awarded an $877.5 million contract to VaxGen, a California company that had never produced a product.

The company stumbled several times, and late last year the government canceled the contract. VaxGen is appealing the decision.

Emergent wants to fill the gap in the stockpile, but it's not clear how it would get to that point. The company's vaccine technology was not eligible for an award under the original Bioshield contract. The government would have to issue new requests under another Bioshield contract, which it hasn't done, or it could add to a contract with Emergent that it has outside Bioshield. The government has added to that contract once, when it increased its 2005 order from 5 million to 10 million doses.

An HHS spokesman could not be reached for comment.

The company also has to overcome lingering questions about the safety of its vaccine, which has caused controversy in the military, with soldiers complaining about significant side effects and with some refusing to be injected. A court battle temporarily stopped mandatory vaccinations, but the military resumed vaccinations after the Food and Drug Administration said the product was safe and effective.

Michael Greenberger, the director of the Center for Health and Homeland Security at the University of Maryland, said the FDA's ruling has not persuaded everyone in the skeptical vaccine community. "The vaccine," he said, "does not have a good reputation in the medical science community."

Emergent executives bristle at such claims, pointing to numerous studies that they say show the vaccine to have no more side effects than other vaccines. Several of the company's senior executives said they had taken the vaccine without any issues.

Tom Waytes, who heads up medical affairs for Emergent's division in Michigan, said any negative attention around the vaccine was being generated by anti-vaccine activists. "That buzz isn't coming from people who know vaccinology," he said.

Emergent is doing its best to get that message out and persuade lawmakers and federal health officials to more strongly consider its vaccine. The company has several lobbying groups working on its behalf, according to recent disclosure forms filed with the government. Also, the company's board includes Louis W. Sullivan, who was health and human services secretary from 1989 to 1993, and Jerome M. Hauer, a former senior HHS official who oversaw public health emergency preparedness.

"We would hope the government would get as excited about this as we are," chief executive El-Hibri said.

March 24, 2007

Corps Outlines Who Gets Anthrax Shots

There’s another needle on the pre-deployment medical checklist for Marines headed to Iraq, Afghanistan or Korea. Everyone heading to the Middle East or Pacific regions is getting the anthrax vaccine, according to a March 19 Corps-wide message.

In February 2006, based on the findings of a Food and Drug Administration analysis of the vaccine, a U.S. Appeals Court dissolved a U.S. District Court injunction that had halted mandatory anthrax vaccinations throughout the military in late 2004. In October, the Defense Department authorized the services to restart immunizations, according to MarAdmin 190/07.The anthrax vaccine is mandatory for nearly all Marines serving in U.S. Central and Pacific commands for more than 15 days. Pregnant Marines get a deferment, and some other medical conditions require exemption, according to the message.

“Commanders will manage immunization refusals as they would address any refusal to obey a lawful order,” the message reads.

The policy allows Marines younger than 18 or older than 64 to opt out of the anthrax vaccination. The Corps is not allowed to make the vaccine mandatory for these Marines because the FDA tests didn’t include them in the sample population, according to the message. However, they can volunteer to take it.

For everyone else within the age range, “the vaccine is safe and effective,” the message said.The mandatory immunizations will also apply to stateside members of Marine Corps Forces Special Operations Command and reservists, individual augmentees, and Defense Department civilians deployed or slated to deploy to South Korea or the Middle East, according to the message.

Marines slated to deploy can begin the immunization process up to 60 days before their departure.

Voluntary for some

Certain other categories of people can volunteer for the shots, including active-duty or Reserve Marines who have received at least one dose of the vaccine and aren’t subject to the mandatory vaccination.

Adult family members of military and civilian personnel going to the CentCom or PaCom areas for more than 15 consecutive days can also volunteer to take the shots.

The vaccination policy requires medical facilities to institute “quality controls” over the pre-screening of Marines “to prevent errors” such as “mandatory vaccinations of Marines in the voluntary category.”

There’s a tri-fold handout involved, according to the message. You’ll need to read that in the clinic.

A Defense Department Web site also offers PowerPoint presentations about the vaccine for individuals, as well as leaders tasked by the message to implement the vaccination program at their units and “properly identify and educate personnel.”

Units are not authorized to begin vaccinations until they register with the Defense Department’s Military Vaccination Agency by submitting an agreement that “affirms they have read the program requirements, completed training and will ensure the program requirements are followed,” according to the policy.

Monthly vaccination reports must be submitted to the agency, which will also track “unauthorized vaccinations” by requiring units to immediately disclose “a full explanation of the circumstances involved, including the number of personnel,” according to the message.

BioThrax is the only FDA-approved vaccine for anthrax. It's also Emergent's only marketable product.

Others are in various stages of clinical testing.

Emergent makes it BioThrax anthrax vaccine at its Lansing facility, the former BioPort Corp.It employs more than 300 workers there and is building a $75 million expansion at the vaccine manufacturing facility.

Anthrax Shots are Back at Pacific Bases

YOKOSUKA NAVAL BASE, Japan — As of Monday, all four U.S. military branches in the Pacific had resumed mandatory anthrax vaccinations for selected servicemembers deploying to “high-threat” areas in the Middle East and the Korean peninsula.

The vaccination mandate affects thousands of servicemembers across the Pacific after two years of the shots being voluntary.

Many sailors at Yokosuka Naval Base hadn’t heard about the Navy’s recently announced Anthrax Vaccination Immunization Program, or AVIP, which requires vaccination for 6,640 sailors in the forward-deployed naval forces.

Specifics on how and when the vaccinations will start are still being determined, U.S. 7th Fleet spokesman Lt. Steve Curry said in an e-mail.

Once that’s done, “every sailor who is part of the mandatory vaccination program will receive comprehensive information on the vaccine,” Curry said.

The III Marine Expeditionary Force on Okinawa also is working on an implementation plan, III MEF spokesman 1st Lt. Garron Garn said.

The Marine Corps instruction, released Monday, calls for mandatory shots for an unspecified number of Marines deploying to Central Command and those assigned or designated as early deployers — troops who would arrive within 20 days of the start of the flow of forces during a conflict — to the Korean peninsula.

Historically, 18,000 Marines are stationed in Okinawa, though 4,000 to 6,000 are deployed at any given time, Garn said.

Airmen at Kadena Air Base in Okinawa soon will start receiving the mandatory vaccine, and the medical clinic expects to immunize 1,000 airmen a year, according to 18th Wing Public Affairs.Misawa Air Base and Air Force bases in South Korea have started giving shots, as the Air Force and Army issued their policies last month. Officials at Yokota Air Base, Camp Zama, and Camp Fuji did not respond to queries about their vaccination plans.

The vaccine is also mandatory for Defense Department civilian employees deemed “emergency essential” or “mission essential” government contractors, but vaccination has to be spelled out in their contracts.

The vaccine, called Anthrax Vaccine Absorbed, is given as a six-shot series over an 18-month period. Each command will administer and track the shots through an AVIP registry agreement.U.S. Naval Hospital Yokosuka hasn’t ordered the vaccine yet because it was waiting for the Navy directive, hospital Preventive Health Director Lt. Lori Christensen said.

“But we are ready with the needles,” Christensen said.

The hospital will be responsible for the voluntary part of the directive, which applies to DOD civilians, family and nonspecified active-duty personnel who started the series previously and want to finish it. Christensen said she is not expecting a big rush.

“We’ve only had one person in the last two and a half years request the shot,” Christensen said. “It doesn’t happen very frequently, but we’ll have it on hand for those who want it.”

Military anthrax vaccinations began in 1998, but the program was halted in 2004 after a federal judge ruled that the Food and Drug Administration made mistakes in determining the vaccine was safe.

The judge allowed voluntary vaccinations to resume in 2005, but only 50 percent of servicemembers in high-threat areas volunteered for the vaccine, according to the DOD.

That put servicemembers “at risk, jeopardized unit effectiveness and degraded medical readiness,” according to a statement from the Office of the Secretary of Defense.

The Department of Defense resumed the mandatory vaccinations last year for U.S. troops and specified civilians serving in CENTCOM and on the Korean peninsula.

But anti-vaccination groups say the vaccine has caused birth defects, Gulf War illness and flu-like side effects in servicemembers. Two attorneys filed a lawsuit challenging the legality of mandatory anthrax vaccinations.

Although Seaman Rachel Lux’s ship, the Yokosuka-based USS Mustin, is not on the mandatory list, she has heard things about the side effects of the vaccine that would cause her to think twice before taking the shots, she said.

“I don’t know if we’re going to get it or not – but I would do my best not to take it,” Lux said. “We take too many shots already.”

While the Kitty Hawk’s Myles wouldn’t choose to take the vaccine, he “has a job to do,” he said.

Refusing Anthrax Shot Means Disobeying Order

Since the military instituted the anthrax vaccination program in 1998, several servicemembers have refused to take the vaccine.

Then — and now, with the resumption of the policy mandating the shots — a refusal officially becomes “a commander’s decision regarding failure to obey a lawful order,” according to the Anthrax Vaccine Immunization Program.

In early 2001 on Okinawa, three servicemembers were convicted of refusing direct orders to begin the series of six anthrax vaccinations mandated by the Department of Defense. Here’s a brief rundown of their cases:

Petty Officer 3rd Class David Ponder, 21, a Navy Seabee, was busted two pay grades to E-2 and sentenced to 60 days confinement. Ponder refused the shots when his Gulfport, Miss., unit was preparing for a six-month deployment to Okinawa and South Korea.

Marine Pfc. Vitalino Arroyo, 20, was busted to private, sentenced to 105 days confinement and fined $1,800 for refusing a direct order to take the anthrax vaccine. Arroyo, attached to the 3rd Battalion, 2nd Marines on Camp Lejeune, N.C., was on a six-month deployment when he refused to take the shots with his company on Camp Schwab, Okinawa. Arroyo testified that he was afraid of possible adverse reactions to the vaccine.

Arroyo and Stonewall were among eight Marines who refused the vaccinations at Camp Schwab. During testimony in Stonewall’s case, a Marine officer said Arroyo and Stonewall requested courts-martial. The other Marines took nonjudicial punishment for their refusals.

During their separate trials in January 2001, the two Marines and the Seabee said they had decided the anthrax vaccination was unsafe after researching it on the Internet.

They said they had learned that the sole provider of the vaccine had been cited by the federal Food and Drug Administration for multiple health violations.

Ironically, the servicemembers were not required to take the vaccine after their trials — the program had been suspended because of a shortage of the vaccine.

Those in the military who believe they were wrongly punished after a judge halted the mandate in 2004 can seek a correction of their military records, according to the Office of the Secretary of Defense.

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the company’s Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body.

Pending the standard 30-day FDA review period, the company expects to initiate a pivotal clinical trial in 2007 in order to evaluate AIG safety and pharmacokinetics in 105 healthy volunteers.

“The filing of this IND for our AIG product candidate is a significant step as we continue to expand our anthrax biodefense product franchise, which includes BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax and an enhanced anthrax vaccine,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Our AIG product, which we are developing in part with grant funding from the NIAID, is an important element of our efforts to develop safe and effective medical countermeasures to help protect the nation against biological attack.”

The company anticipates that the clinical trial for its AIG candidate will be completed within approximately one year from its commencement date and that no additional clinical trials will be required prior to submitting an application to FDA for marketing approval. The company, which is relying on the FDA animal rule in developing its AIG candidate, expects to conduct pivotal efficacy studies in two animal models, with the timing of those studies dependent upon completion of the development of the models in collaboration with the U.S. government. The company believes that favorable data from these clinical and non-clinical studies would be sufficient to support an application to the FDA for approval of its AIG candidate.

During 2006, the National Institute of Allergy and Infectious Diseases (NIAID) agreed to provide funding to the company of up to $3.7 million to support pivotal animal studies and for the development and validation of product assays.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, consisting of vaccines and therapeutics that induce or assist the body’s immune system to prevent or treat disease.

The company’s biodefense business is focused on immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on development, manufacture and commercialization of immunobiotics for use against infectious diseases. These immunobiotics are designed to address significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our performance under existing BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

In the first case of its kind in years, a 2-year-old boy is being treated in Chicago for a rare and life-threatening infection that he contracted from his father, a U.S. Army soldier recently vaccinated against smallpox.

The Indiana boy is in critical condition with eczema vaccinatum, an unusual side effect of the smallpox vaccine that can affect people who receive the shot or their close contacts.

Doctors also said the boy appears to have passed the infection to his mother, who has a much milder case of the virus in the smallpox vaccine, which is also called vaccinia. The virus is not smallpox, though it is similar enough to offer protection from that deadly disease, which was declared eradicated in 1980.

The mother and child are being treated at the University of Chicago's Comer Children's Hospital, which withheld their names at the family's request. There is no infection risk for the general population, government officials say, since the vaccine virus can spread only through close physical contact.

But the boy's diagnosis last week has prompted a frenzy of activity and daily conference calls involving the federal Centers for Disease Control and Prevention, the U.S. Department of Defense, and the state and city public health departments. The U.S. Food and Drug Administration gave emergency authorization for the hospital to treat the boy with ST-246, an experimental drug for smallpox that is untried as a therapy in humans.

The smallpox vaccine fell out of general use in the 1970s, but the case could be a lesson for the U.S. military, which has vaccinated 1.2 million personnel against smallpox since 2002 amid fears of bioterrorism.

It's unclear why the father was allowed to have contact with his son, who had a history of eczema, shortly after the vaccination. The skin condition is a well-known risk factor for eczema vaccinatum, and official guidelines warn that people with eczema should avoid contact with vaccinees.

"We are looking into how this could have happened," said U.S. Army spokesman Paul Boyce.

Officials say the general population could receive smallpox vaccinations in the event of a bioterrorist attack or other unforeseen exposure. For that reason, experts want to study the Indiana family to learn more about treatment and transmission of the vaccinia infection.

"There certainly are also conceivable insights into smallpox infection," said Dr. Inger Damon, chief of the CDC's poxvirus and rabies branch. Damon has been involved in the daily conference calls on the boy's treatment.

Experts said they knew of no cases of eczema vaccinatum since at least 1990, when the military last had a program of smallpox vaccination.

The vaccinia virus in modern smallpox vaccines is closely related to an older form of vaccinia called cowpox, the disease English doctor Edward Jenner used in the late 1700s to develop early methods of vaccination.

Jenner relied on the observation that milkmaids who had cowpox seemed to be protected from later smallpox infection. He found that patients inoculated with material from cowpox sores also got protection from smallpox. That history is why the word vaccine stems from the Latin word for cow.

Vaccinia was modified from its original form over the years but remains an infectious agent with the potential for side effects.

The father of the Indiana boy received the vaccine in late January before a planned military deployment. The Army delayed his departure and permitted him to visit his family in mid-February.

Two weeks later, a rash broke out on the boy's skin. He came to the U. of C. on March 3 after being transferred from St. Catherine's Hospital in East Chicago. Doctors first identified his widespread rash as a different form of eczema, but it worsened in his first few days at the U. of C.

His mother developed sores after she and her son arrived at the Chicago hospital. Doctors believe she contracted the disease from the boy because of their lengthy close contact.

A pediatric dermatologist, Dr. Sarah Stein, noticed the boy's lesions had changed to look like round blisters with a dimple in the middle-- a potential sign of vaccinia infection. The medical team took scrapings from the lesions, which they analyzed and sent to the Illinois Department of Public Health's Chicago office for further testing.

Rapid tests by the state and further tests at the CDC confirmed the boy had the vaccinia virus, officials at those agencies said. The hospital also sent the CDC photos of the boy's lesions.

The hospital already was using infection precautions with the boy, but staffers then added such measures as gloves and face masks. They also placed the boy in a room with negative pressure so the air would always blow inward, keeping the virus inside.

The boy's rash had spread to cover 80 percent of his body, said Dr. Madelyn Kahana, chief of pediatric intensive care medicine at the U. of C. He was going into sepsis, a devastating, systemwide infection rarely seen with viral cases.

"In the later stages of [eczema vaccinatum], it can look like smallpox," said Damon of the CDC.

The boy needed a ventilator to help his breathing because of the powerful pain medication he needed for the lesions.

The boy received the primary treatment for eczema vaccinatum, a drug called vaccinia immune globulin, or VIG. The drug came from a stockpile the CDC keeps in case widespread vaccination ever becomes necessary.

He also got an antiviral drug called cidofovir and the experimental drug ST-246, which has been shown to protect laboratory animals from exposure to smallpox. The drug recently entered preliminary human trials but had never been used in a sick patient.

U. of C. officials said the boy has shown signs of improvement since hitting a low point last weekend. His mother's health was never in serious danger, but she has remained in his hospital room to keep others from being exposed. Health officials in Chicago and Indiana have tracked all of the family's contacts and found no additional cases so far.

Kahana said the boy probably will lose 20 percent of his outer skin layer, but she hopes he will recover without the need for skin grafts. She believes the case should be a lesson to the military, which must educate service members about the risks of the vaccines it requires them to take.

"I think the information simply wasn't disseminated properly or impressed in a manner that was understood," Kahana said, "because I don't think anyone would knowingly expose their child to this."----------

Navy adds to the list of those in Pacific who must get anthrax vaccinations

1) The Navy can compel family members to get vaccinated in case of emergencies, according to BUMED.

2) “Under certain public health provisions and emergencies, the Navy can require individuals to receive a vaccine as a condition of remaining on a Navy installation or being allowed to enter or leave a Navy installation,” according to BUMED.

3) “The question is necessary to inform women and providers of the possibility of becoming pregnant,” the BUMED statement says. “This offers a higher level of protection to the female and a potentialfetus.”

Navy adds to the list of those in Pacific who must get anthrax vaccinationsBy Jeff Schogol, Stars and StripesPacific edition

ARLINGTON, Va. — Sailors in Japan are again required to get mandatory anthrax vaccinations, the Navy has announced.

Sailors who previously received anthrax vaccine can elect to continue “to complete their initial series and/or receive their annual booster,” according to an e-mailed response to questions from the Navy Bureau of Medicine and Surgery.

In a recent NAVADMIN (Navy Administrative Message), the Navy announced the following sailors and Marines will also have to get the anthrax shots: “U.S. Pacific Command forward deployed naval forces and III Marine Expeditionary Force assigned or designated as early deployers [up to 20 days after the start of the flow of forces] to the Korean peninsula.”The Navy said the move would affect sailors on ships forward-deployed to Japan including:The aircraft carrier USS Kitty Hawk, with a crew of 3,000 sailors and an additional 2,000 air crew.The amphibious assault ship USS Essex, with a crew of 950 and the capacity to hold 1,073 troopsThe cruiser USS Shiloh, with a crew of 387.The destroyer USS Curtis Wilbur, with a crew of 303.The move would not affect most sailors in Guam, said Navy spokeswoman Lt. Ligia Cohen.

“The sailors in Guam are not considered forward deployed except a few units with special missions,” Cohen said in a Thursday e-mail to Stars and Stripes.The Marine Corps would not say Thursday how many Marines on Okinawa would have to get the anthrax regimen.

Asked if all III MEF Marines would be required to get vaccinated for anthrax, a Corps official would only say the Corps plans to issue specific guidelines on the vaccination program in an upcoming Marine Administrative Message.

Last year, the Defense Department made anthrax vaccinations mandatory again for U.S. troops and some department civilians serving in the U.S. Central Command theater of operations and on the Korean peninsula.

The Defense Department began vaccinating troops against anthrax in 1998, but a federal judge stopped the program in 2004 after finding the Food and Drug Administration made mistakes in determining that the vaccine was safe.

The judge allowed the Defense Department to administer the vaccinations on a voluntary basis beginning in 2005, but when only half of servicemembers decided to get vaccinated, the Defense Department made the vaccinations mandatory again for troops heading to the CENTCOM area of operations and Korea.

Adults who accompany troops and contractors to those regions can still receive the vaccinations on a voluntary basis, the NAVADMIN says.The Navy can compel family members to get vaccinated in case of emergencies, according to BUMED.

“Under certain public health provisions and emergencies, the Navy can require individuals to receive a vaccine as a condition of remaining on a Navy installation or being allowed to enter or leave a Navy installation,” according to BUMED.

Pregnant women will only receive the vaccine in “unusual circumstances if the potential benefits of the vaccination outweigh the potential risks to the fetus,” the NAVADMIN says.

The NAVADMIN recommends asking women if they are pregnant or if there is a chance they could become pregnant during the next month before administering the shot. The query is a standard question posed to female servicemembers and civilians before they are vaccinated, not a way of asking if women are sexually active, according to BUMED.

“The question is necessary to inform women and providers of the possibility of becoming pregnant,” the BUMED statement says. “This offers a higher level of protection to the female and a potential fetus.”

March 16, 2007

Patch Work

For an emerging biotech, Iomai’s business plan is straightforward: Save millions of lives worldwide and safeguard the nation against pandemic flu while exploiting a $3 billion-a-year market.

The 10-year-old Gaithersburg company took a significant step toward that ambitious goal last month when it finally got its ‘‘company maker,” as founder Gregory Glenn put it: a federal contract worth up to $128.4 million to get into human trials its immune-boosting skin patch for bird flu vaccines.The government hopes Iomai’s ‘‘ouchless” patch — similar to a Band-Aid, Glenn said — will provide the nation with a ready supply of bird flu vaccine in case a pandemic threatens.

When the Department of Health and Human Services awarded the contract to Iomai, it also awarded bird flu vaccine contracts to pharmaceutical giants GlaxoSmithKline and Novartis.‘‘That’s good company to be in,” Glenn said, ‘‘and it’s a company maker for us.”Annabel Samimy of global financial firm UBS, agrees.

‘‘We view this as validation of Iomai’s ultimate goal of establishing broad utility,” Samimy said. As a result, a UBS report predicts Iomai will turn a profit by 2010.

Also working on developing various medical patch treatments are BioElectronics Corp. of Frederick, Sequella Inc. of Rockville and British firm Shire Pharmaceuticals, which has a plant in Owings Mills.

Saving children from flu

Delivering a bird flu vaccine isn’t its patch’s only application, Iomai says. Its patented technology is also suitable for better protection than injected vaccines against seasonal flu in the elderly and in millions of infants and children in developing nations. It also can quickly adapt to changes in influenza strains, either seasonal flu or bird flu, company officials say.

Unlike injected vaccines, the Iomai patches do not require refrigeration. They are made of dead virus antigens that are dried and will not spread to other people if exposed to the air.Using a patch, health care workers in developing countries would not need special training to immunize a population, Glenn said.

‘‘We want to break the refrigeration chain,” he said. ‘‘It would make it possible to do a mass immunization campaign without having everyone go to a central city.”

Another advantage of the patch: It cuts the amount of flu vaccine needed to confer immunity by 90 percent, he said.

‘‘We are trying to make enough for everyone in advance,” Glenn said. ‘‘So if you can make a smaller dose — let’s say you can normally make 10,000 doses — you can decrease the dose by ten-fold and have 100,000 doses. So our patch, added at the time of a pandemic, would be a dose-sparing effort.”

In the past five years, the bird flu virus strain H5N1 has infected millions of poultry in Asia and Europe. There have been only 277 human infections and 167 deaths have been linked to outbreaks in 12 nations. Although no cases of a human infecting another human have been reported, epidemiologists say vaccines would be the best option to stop the virus if it mutates into a contagious human strain and leads to a pandemic.

The federal government has never approved a patch vaccine, but will likely use the same guidelines for approval as with other vaccine modes, say agency officials.

Iomai has already advanced three patch-based products to clinical trials and is working on an anthrax vaccine patch.

Also, the company’s booster patch for the elderly is in phase 2 trials. It is designed to boost immunity in seniors, who may have an immune response to vaccinations as much as 30 percent lower than younger patients. Placed over the skin point punctured by an injected vaccine, the patch stimulates response to the vaccine.

Sales of the booster patch could reach $300 million a year, the company says.

Iomai, which went public late last year, has grown from 66 employees in 2005 to 120. As of Dec. 31, the company reported $15.33 million in cash, with revenues of $1.48 million and a net loss of $30 million for 2006.

But Iomai faces competition from two other companies developing flu vaccine patches with funding from the National Institutes of Health, said David S. Cho, influenza product development program officer at NIH in Bethesda.

SRI International of Menlo Park, Calif., is developing a transdermal vaccine delivery research for influenza. Universal Stabilization Technology Inc. of San Diego received funding to develop alternative vaccine delivery routes similar to the skin patch.

At Iomai, Glenn, who is a pediatrician, is also excited about the company’s vaccine patch for an altogether different ailment: traveler’s diarrhea, which takes a devastating toll on children worldwide.

Iomai hopes to tap into a $450 million market with the treatment, which is scheduled for phase 3 trials early next year. The patch contains enterotoxigenic E. coli bacteria, which causes most cases of traveler’s diarrhea and causes sickness and death to millions of children in developing countries.

‘‘I would love to have our traveler’s vaccine, ETEC, get into the infants’ and children’s area,” Glenn said. ‘‘It would be very exciting. If you aren’t healthy, you can’t learn, and these types of insults can have a large impact on a child’s health and mentality.”

Iomai plans to sell its flu vaccine patches in packages that people can buy at a drugstore to vaccinate themselves.

The Iomai patch vaccine could be a new beginning in vaccines, said Dr. Neal A. Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health in Baltimore.

‘‘It will be wonderful if it works,” Halsey said. ‘‘They can be applied by people with not much training. And here in our clinics you could give more influenza vaccines. Right now, some people are throwing away vaccine, and other people can’t get it on time.

‘‘We could mobilize an army of people to give vaccines,” he said. ‘‘You would not have to create crowds of people, which creates more exposure.”Medical patch industry

Medical patch treatments have been on the market since 1979 when the FDA approved a patch for motion sickness. Other patches treat nicotine addiction, chronic pain, estrogen replacement, bladder control, depression, osteoarthritis and other conditions. Besides Iomai, these Maryland companies are in the medical patch field:BioElectronics Corp. of Frederick makes drug-free patches that deliver mild electromagnetic pulses to muscle swelling from wounds and surgeries.

Sequella Inc. of Rockville is developing a patch to diagnose active tuberculosis infections.British firm Shire Pharmaceuticals, with a manufacturing facility in Owings Mills, is developing a one-a-day patch for attention deficit hyperactivity disorder in children 6 to 12 years old.

March 15, 2007

Chickenpox Vaccine Effects Different than Originally Claimed - More Severe Ilness as Protection Fades

Effects of chickenpox vaccine fade over timeBy Gene Emery

Merck's chickenpox vaccine Varivax not only loses its effectiveness after a while, but it has also changed the profile of the disease in the population, U.S. researchers reported on Wednesday.

The study confirmed what doctors widely knew -- that the vaccine's protection does not last long.

And with fewer natural cases of the disease going around, unvaccinated children or children in whom the first dose of the vaccine fails to work have been catching the highly contagious disease later in life, when the risk of severe complications is greater, they said.

"If you're unvaccinated and you get it later in life, there's a 20- times greater risk of dying compared to a child, and a 10 to 15 times greater chance of getting hospitalized, " said Jane Seward of the Centers for Disease Control and Prevention in Atlanta, who worked on the study.

The findings, reported fully for the first time in Thursday's New England Journal of Medicine, have already had an impact.

They helped prompt the CDC's Advisory Committee on Immunization Practices to recommend a booster shot between the ages of 4 and 6. The panel also said in its June 2006 report that children, adolescents and adults should be given boosters as well.

No one knows how long the effects of a second shot will last, said the research team, led by Sandra Chaves of the CDC.The United States has been vaccinating against chickenpox, also known as varicella, since 1995. But tests have show that the vaccine is not very effective in 15 to 20 percent of children who only receive one dose.

A second dose will certainly provide extra protection, but it is not clear how much. "Instead of 80 to 85 percent efficacy, we're hoping instead to see 90 to 95 percent for the second dose," said Seward, acting deputy director of the CDC's division of viral diseases.

The Chaves team used vaccination and illness data from Antelope Valley, California, northeast of Los Angeles, to track Varivax's effectiveness.

The shots cut the number of cases by 85 percent between 1995 and 2004. In 1995 just 1 percent of the 2,794 reported cases were among children who had been vaccinated. In 2004, there were far fewer cases -- 420 -- but 60 percent were in vaccinated children.

While 73 percent of the youngsters who became ill in 1995 weere under age 7, the rate dropped to 30 percent by 2004 because the children who got chickenpox tended to get it at an older age.

And when vaccinated children were infected, they tended to be sicker, probably because they were older.

"Children between the ages of 8 and 12 years who had been vaccinated 5 years or more previously were two times as likely to have moderate- to-severe breakthrough disease as were those who had been vaccinated less than 5 years previously," the researchers wrote.

Last May another vaccine made by Merck to act as a booster for adults, Zostavax, was approved.

The chickenpox virus remains in the body for life and can be reactivated as shingles, a rash that can cause pain that persists for years.

Chickenpox is often considered a harmless childhood disease, but before vaccination, 100 children died each year from complications of chickenpox in the United States alone.

Emergent BioSolutions Gains Rights To VaxImmune™ From Coley Pharmaceutical Group to Expand Its Anthrax Franchise

Emergent BioSolutions Gains Rights To VaxImmune™ From Coley Pharmaceutical Group to Expand Its Anthrax Franchise

Agreement Allows Company to Build on Promising Phase I Results of BioThrax® (Anthrax Vaccine Adsorbed) Combined With VaxImmuneTM

ROCKVILLE, Md.--(BUSINESS WIRE)--

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a license agreement with Coley Pharmaceutical Group, Inc. (Nasdaq:COLY) for the use of Coley’s proprietary VaxImmuneTM vaccine adjuvant compound. Emergent intends to utilize VaxImmune in the development of new anthrax vaccines. Financial terms of the license agreement were not disclosed.

Coley’s VaxImmune is a proprietary Toll-like receptor 9 (TLR9) agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response to infections in order to achieve and sustain a clinical response without compromising safety.

“As a leading developer of both biodefense and commercial vaccines and therapeutics, we continually assess novel adjuvant technologies as a critical component of our development strategy,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We believe that gaining access to a promising adjuvant technology like VaxImmune provides us a distinct advantage. This adjuvant has the potential to significantly enhance immune responses. Securing rights to VaxImmune demonstrates our commitment to developing our anthrax franchise, which includes BioThrax® (Anthrax Vaccine Adsorbed), the only FDA licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax, an enhanced anthrax vaccine and an anthrax immune globulin (therapeutic).”

The agreement allows the company to build on promising data from a Phase I clinical study funded by the Defense Advanced Research Projects Agency (DARPA) of the DoD. This double-blind Phase I clinical trial was designed to evaluate the safety and immunogenicity of a combined product candidate using BioThrax and VaxImmune compared to BioThrax alone and VaxImmune alone. This human trial, developed through a collaboration among DARPA, Coley and Emergent BioSolutions, and completed in 2005, involved 69 healthy volunteers and used a three-dose regimen and intramuscular route of administration. The immunogenicity results from this trial were promising. Specifically, the mean peak concentration of antibodies to anthrax protective antigen in participants who received BioThrax plus VaxImmune was approximately 6.3 times higher than in participants who received BioThrax alone. In addition, this mean peak concentration of antibodies to anthrax protective antigen was achieved in approximately three weeks after first injection in participants who received BioThrax plus VaxImmune, which is approximately 21 days sooner than in those participants who received BioThrax alone.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body’s immune system to prevent or treat disease. The company’s biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on developing immunobiotics for use against infectious diseases which pose significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our performance under existing BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release

Lift the Curtain - Editorial

Why in the world is anyone surprised that the Bush administration has not been taking good care of wounded and disabled American troops?

Real-life human needs have never been a priority of this administration.

The evidence is everywhere - from the mind-bending encounter with the apocalypsein Baghdad, to the ruined residential neighborhoods in New Orleans, to the anxious families in homes across America who are offering tearful goodbyes to loved ones heading off to yet another pointless tour in Iraq.

The trial and conviction of Scooter Libby opened the window wide on the twisted values and priorities of the hawkish operation in the vice president's office. No worry about the troops there.

And President Bush has always given the impression that he is more interested in riding his bicycle at the ranch in Texas than in taking care of his life and death responsibilities around the world.

That whistling sound you hear is the wind blowing across the emptiness of the administration' s moral landscape. U.S. troops have been treated like trash since the beginning of Mr.Bush's catastrophic adventure in Iraq. Have we already forgotten that soldier from the Tennessee National Guard who dared to ask Donald Rumsfeld why the troops had to go scrounging in landfills for "hillbilly armor" - scrap metal -to protect their vehicles from roadside bombs?Fellow soldiers cheered when the question was raised, and others asked why they were being sent into combat with antiquated equipment. The defense secretary was not amused. "You go to war with the Army you have," he callously replied, "not the Army you might want or wish to have at a later time."

Have we forgotten that while most Americans have sacrificed zilch for this war, the mostly uncomplaining soldiers and marines are being sent into the combat zones for two, three and four tours? Multiple combat tours are an unconscionable form of Russian roulette that heightens the chances of a warrior being killed or maimed.

In the old days, these troops would have been referred to as cannon fodder.

However you want to characterize them now, their casually unfair treatment is an expression of the belief that they are expendable.

The Washington Post has performed an important public service by shining a spotlight on the contemptible treatment that some soldiers received as outpatients at the Walter Reed Army Medical Center.

The series has already prompted Congressional hearings, and the president climbed off his bicycle long enough to appoint the requisite commission.

Thequestion is whether Congress and the public can be roused to take action on behalf of the troops.

It's not just the indifference and incompetence of the administration that are causing the troops so much unnecessary suffering. The simple truth is that the Bush crowd, busy trying to hide the costs of the president's $2 trillion tragedy in Iraq, can't find the money to pay for all the care that's needed by the legions of wounded and mentally disabled troops who are coming home.

The outpatient fiasco at Walter Reed is just one aspect of avast superstructure of suffering. The military is overextended and falling apart. Equipment worn out or destroyed by the wars in Iraq and Afghanistan has to be replaced. The perennial, all-consuming appetite of the military-industrial complex has to be satisfied. And now, here comes that endless line of wounded men and women, some of them disabled for life.

How is all of this to be paid for?

The administration has tried its best to keep the reality of the war away from the public at large, to keep as much of the carnage as possible behind the scenes. No pictures of the coffins coming home. Limited media access to Walter Reed.

That protective curtain needs to be stripped away, exposing the enormity of this catastrophe for all to see.

I remember walking the quiet, manicured grounds of Walter Reed on an unauthorized visit and seeing the young men and women moving about in wheelchairs or on crutches. Some were missing two and three limbs. All had suffered grievously.

There is something profoundly evil about a country encouraging young men and women to go off and fight its wars and then shortchanging them on medical care and other forms of assistance when they come back with wounds that will haunt them forever.

March 12, 2007

Army's Kiley Ousted in Walter Reed Furor

WASHINGTON — Army Surgeon General Kevin C. Kiley abruptly stepped down under pressure from military superiors, the third top Army official forced out in the fallout from revelations of shabby treatment of wounded soldiers at Walter Reed Army Medical Center.

The Army said Monday that Lt. Gen. Kiley had submitted a request to retire over the weekend. Acting Army Secretary Pete Geren had asked Kiley for his retirement, said a senior defense official, speaking on condition of anonymity because he was not authorized to talk about the events.

Kiley's removal underscored how the controversy, which began with reports of dilapidated outpatient housing and a nightmarish bureaucracy at the Army's flagship hospital, has snowballed into a far broader problem for the Bush administration.

Congressional committees and a slew of investigative boards are scrutinizing the treatment of wounded troops and veterans by the military's entire medical system, as well as by the Department of Veterans Affairs, headed by Jim Nicholson. The probes come with the administration already struggling to defend its widely unpopular war policies in Iraq, and the Democratic-led Congress citing poor care for troops as the latest instance of incompetent administration planning for the conflict.

Kiley, 56, who headed Walter Reed from 2002 to 2004, has been a lightning rod for criticism over conditions there and has been a frequent target of hostile questions at congressional hearings.

"The events of late _ failures by some, failures in our system _ have tarnished the reputation of us all," Geren told 280 Walter Reed workers Monday. "The American people expect us to fulfill our obligation to those who have borne the battle" and are angry and disappointed when they see failure.

Geren has had his position for less than two weeks, having replaced Army Secretary Francis Harvey, who was dismissed March 2. Maj. Gen. George W. Weightman, who had been in charge of Walter Reed since August 2006, was ousted from his post the day before.

In a statement released by the Army, Kiley said, "I submitted my retirement because I think it is in the best interest of the Army." He said he wanted to allow officials to "focus completely on the way ahead."

"We have failed to meet our own standards at Walter Reed. For that, I'm both personally and professionally sorry," he said last week.

He has said he had been aware of some issues, but he told the Senate Armed Services Committee he was not aware of specific problems including a backlog of maintenance orders and a lack of staff to conduct room inspections.

A specialist in obstetrics and gynecology, he has had numerous medical posts in his Army career including service in South Korea and then in Saudi Arabia during the 1991 war with Iraq.

Soldiers and their families have complained that some outpatient living quarters at Walter Reed had mice, mold and other shoddy conditions and that there were bureaucratic delays at the hospital overwhelmed with wounded from the wars in Iraq and Afghanistan.

Maj. Gen. Gale Pollock, current deputy surgeon general, assumed Kiley's job while a permanent replacement is sought. Kiley remains on active duty during the retirement process, which could take up to two months.

Some lawmakers welcomed Kiley's departure.

However, Rep. Ike Skelton, D-Mo., chairman of the Armed Services Committee, said Kiley's firing alone won't solve the problem. "With the installation of new leaders, the real test will be making sure that the work fixing problems actually gets done," he said.

Rep. Tom Davis of Virginia, top Republican on the House Committee on Oversight and Government Reform, said Kiley "did not seem to understand the scope of his job."

And Sen. Patty Murray, D-Wash., said Kiley's tenure had been "riddled with serious blunders.""We still lack a system that meets the needs of our troops from the battlefield to the local VA and everywhere in between," said Murray, a member of the Senate Democratic leadership.Amid the focus on Walter Reed, VA Secretary Nicholson on Monday ordered his department's clinics to provide details about their physical condition by next week to determine if squalid conditions found at Walter Reed exist elsewhere.

Nicholson has been under pressure to reduce claims backlogs and improve coordination at the VA's vast network of 1,400 hospitals and clinics, which provide supplemental care and rehabilitation to 5.8 million veterans.

In another sign of the administration's effort to contain political damage, President Bush asked Congress Saturday for $50 million in emergency war funding to improve the medical treatment and rehabilitation of service members.

The conditions at Walter Reed were detailed last month by The Washington Post. Since then, Defense Secretary Robert Gates has forced Army Secretary Francis Harvey to resign. Gates was displeased that Harvey had initially chosen Kiley as interim commander of Walter Reed, officials said privately at the time.

Bush has appointed a bipartisan commission to investigate problems at the nation's military and veteran hospitals. Separate reviews are under way by the Pentagon, the Army and an interagency task force led by Nicholson.

The Army moved within days of the Post story to paint and fix some of the outpatient rooms. Officials also have added caseworkers, financial specialists and others to work with soldiers' families on problems such as getting disability pay and obtaining loans.

"We've made a good start, but much remains to be done," Geren told staff members Monday. "I share in your conviction that we will do whatever it takes to do it right."

Aethlon Medical hopes to be ready if and when bioterrorists strike with deadly diseases such as smallpox, Ebola, and Marburg virus.

The San Diego-based company has developed a special filter that it claims can help clear a patient’s blood of deadly pathogens that cause some of the world’s most feared infectious diseases. Aethlon’s “hemopurifier,” which is attached to a portable blood pump or a dialysis machine, is designed to separate and capture viruses and toxins in the bloodstream. That would allow a patient’s immune system to recover enough to battle the pathogens, said Jim Joyce, Aethlon’s CEO.

“The treatment is to augment the natural immune response of clearing viruses and toxins before vital organs can be infected,” he said.

But Aethlon has yet to prove its device works as advertised. The tiny company last week asked the U.S. government for permission to start human trials to evaluate the safety and efficacy of its hemopurifier, the only device yet developed to treat bioterror threats.- ADVERTISEMENT -RandomArticleAd()

Most companies targeting deadly viruses and toxins are drug and vaccine developers such as Brisbane, California-based VaxGen. It was among the first to snag a contract, worth $877 million, from the U.S. government’s BioShield program in 2004 to develop an anthrax vaccine. The government pulled the plug on that project in December after the company failed to meet expectations.

Aethlon expects by the end of 2008 to get approval to use the device against smallpox, Marburg virus, Ebola, or Dengue fever. The bulletin-board-traded company has yet to estimate the price of its filter.

Aethlon inherited the technology in 1999 when it forked over $6 million to buy Buffalo, New York-based Hemex. The technology was originally developed to remove harmful metals from the blood stream. In 2000, Aethlon changed directions and has spent $11 million to develop the technology to treat infectious diseases.

Aethlon also thinks the technology could help doctors treat chronic infectious diseases like Hepatitis C and HIV.

March 9, 2007

Air Force Begins Giving Mandatory Anthrax Shots in Korea

SS Maj. Nerriza Brooks of Osan Air Base's 51st Medical Group gives an anthrax shot to Master Sgt. Daniel Saiz of the 51st Mission Support Squadron on Wednesday.

OSAN AIR BASE, South Korea — The U.S. Air Force in South Korea resumed mandatory anthrax shots for its airmen Wednesday, officials said.

Osan Air Base began mass vaccinations, said Lt. Col. Michael E. Shavers, spokesman for 7th Air Force at Osan. About 4,000 airmen are slated for the shots there, he said.

At Kunsan Air Base, the 8th Fighter Wing was to begin shots Friday for the wing’s 1,600 airmen, said Capt. James P. Lage, a wing spokesman.

This comes after the Pentagon’s top health official approved plans to restart anthrax vaccinations for troops serving in South Korea or in the U.S. Central Command area of operations.

Since 2005 the shots had been voluntary. But when only half of U.S. troops chose to get them, the Pentagon in 2006 announced they would become mandatory for those deemed most at risk.

On Wednesday, the Air Force became the first branch to resume the shots in South Korea, officials at U.S. Forces Korea in Seoul said.

It could not immediately be learned from USFK when the other services on the peninsula are scheduled to begin anthrax shots.

The shots are to be given to all of the nearly 7,900 airmen serving in South Korea, except those who may be deemed exempt for medical or other reasons, officials said.

U.S. Air Force headquarters has set a goal that 90 percent of airmen in South Korea and in the CENTCOM area will have received or started to receive the shots by April 30 and the rest thereafter, Shavers said. The process entails six shots given over 18 months.

At Osan on Wednesday, medical teams staffed tables in the base theater and vaccinated airmen from 6:30 a.m. to 6 p.m., a schedule they were to repeat Thursday, Shavers said. Shots also were being given at the base hospital, and are planned to be given at certain on- base squadrons.

In addition, medical teams are prepared to visit places other than Osan and Kunsan, said Lt. Col. Lee Harvis, commander of the 51st Aerospace Medicine Squadron at Osan.

“If we have to bring it to them, we’ll bring it to them,” he said.

Airmen who say they need to be exempted from the shots on medical grounds will be sent to the base hospital for checks to determine whether an exemption is warranted, Harvis said.

“It’s not our job to force anybody,” Harvis said.

No airmen refused the shot, Harvis said Wednesday afternoon.

Airmen have received medical briefings at their units about the upcoming immunizations, and also are given an informational pamphlet, Harvis said.

Should airmen decline the shot, a medical official will talk with them about their reluctance.

If they still decline, their names are to be noted and they are to discuss their refusal with their squadron commander, said Harvis.

Master Sgt. Daniel Saiz of the 51st Mission Support Squadron got his first anthrax shot in the base theater at Osan on Wednesday.

“I wasn’t interested,” he said, until medics gave a briefing about how lethal even a small quantity of anthrax can be.

U.S. Sen. Jay Rockefeller equates the Walter Reed Army Medical Center scandal to a volcano ready to erupt.

Reports of rodent- and cockroach-infested conditions, stained carpets, black mold and insufficient heat and water at the Army's premier hospital have incited uproar among veterans, families and politicians.

Those accounts of neglect don't surprise Rockefeller, D-W.Va., a longstanding member of the Senate Veterans Affairs Committee.

Rockefeller says this scandal represents just a slice of a larger problem -- the federal government's general disregard for veterans.

He said in a telephone interview that he believes Army veterans are especially neglected and that the Department of Defense -- not the U.S. Department of Veterans Affairs -- is largely to blame.

"The Marines and Navy, they watch over their vets closely," Rockefeller said. "The Army kind of lets them go. You'll find people wandering around Water Reed who can't get medical appointments."

Bethesda Naval Hospital in Maryland is the top medical center for the U.S. Navy. Rockefeller suspects the naval hospital is more accommodating to its patients than Walter Reed, which is in Washington, D.C.

In addition to highlighting the conditions at the Army hospital, The Washington Post also recently outlined the bureaucratic nightmare that wounded or sick soldiers face.

A typical soldier must file 22 documents with eight different commands to enter and exit medical processing. Forms are processed by 16 different information systems, but the Army's three personnel databases can't even interact with each other.

Some soldiers receiving care have had to prove they served in Iraq and Afghanistan.

Maj. Gen. George Weightman, who headed the hospital for only six months, was fired in the wake of the stories. Secretary of the Army Francis Harvey was forced to resign from his position.

Rockefeller said he hopes these actions are a first step in fixing the broad range of problems plaguing the country's combat veterans.

The senator returns to West Virginia several times a year to meet with residents who have fought in various wars. These meetings are private, as Rockefeller never discloses them to the public or media. He doesn't even let his staffers in on the meetings.

"The veterans usually warm up to the senator after a bit, although he sometimes delves into territory they would rather avoid."

After an hour, one of them might say, ‘Hey. Stop right there. You got to a level where I can't handle that pain,' " Rockefeller said.

These interactions -- understanding their problems -- can be just as important as knowing what type of care they're receiving at Walter Reed, he said.

"They go through hell and probably will the rest of their lives," Rockefeller said.

"Sometimes they feel guilty it wasn't them that was killed, or they wake up after being sound asleep and think everyone in the house is an Iraqi ready to kill them.

"The real question is not necessarily what happens at Walter Reed," the senator said.

The Department of Defense has been the real culprit in ignoring veterans' needs, Rockefeller contends.

During the Persian Gulf War, soldiers were given a chemical called pyridostigmine bromide in pill form to prevent harm from exposure to the nerve agent soman. It was believed that soman, which shuts down the function of muscles and the brain, could have been used in a chemical attack on military personnel.

Pyridostigmine bromide, often called PB, was never approved by the Federal Drug Administration. It wasn't even tested on animals.

The Pentagon itself in 1999 said the drug could be linked to Gulf War Syndrome, with symptoms that include chronic fatigue, headaches, skin problems and muscle pain.

Rockefeller said he hired his own staff to research PB and soon came to know veterans who were told to take the drug daily.

One of the veterans was a woman from South Charleston who was experiencing loss of muscle control in her arm.

"I saw men and women who developed such lassitude," Rockefeller said. "They couldn't get up in the morning or read newspapers. Some had blotches on their faces. Some lost their day jobs.

"When American forces bombed the southern village of Camassia in Iraq, a cache of chemical weapons exploded. It was later determined that the PB drug given to soldiers had no effect in combating exposure to those chemicals.

The federal government didn't do its homework on the drug when issuing it to soldiers, Rockefeller insists.

After returning home, several soldiers began experiencing symptoms. At veterans' hospitals, doctors would literally tell veterans to "go home and take aspirin," Rockefeller said.

Agent Orange, the herbicide and defoliant widely sprayed on dense jungle areas and waterways during the Vietnam War, is another product that is believed to have caused harm to soldiers.

Veterans affected by the herbicide weren't compensated until the death of an admiral's son brought the issue to light.

Retired Admiral Elmo Zumwalt, a U.S. Navy commander in Vietnam who actually ordered the spraying of Agent Orange, blamed the defoliant for the death of his son, who had Hodgkin's disease and rare lymphoma."It was used as a defoliant, but it defoliated a lot of lives," Rockefeller said.

At a Walter Reed hearing this week, Rockefeller asked why the Veterans Administration and Department of Defense didn't share records with one another. He discovered that the Department of Defense actually keeps some soldiers' files on paper only.

The department does not keep computerized medical records, he said.

"What an absolutely incredible lack of communication, and frankly, a total indifference shown by the DOD to its soldiers once they are finished with them," Rockefeller said.

Perhaps the Walter Reed controversy will shift focus to the treatment and care of returning soldiers rather than sending more into combat, he said.

"The strongest point I can make is that not one dime for the wars in Iraq and Afghanistan is coming from the federal budget," Rockefeller said.

"It's all borrowed, mostly from Japan, South Korea and European banks. If it's borrowed, you don't have to worry about anything. You've got all you need. But the V.A. has to live within a budget and live by it."

There's an American instinct that says to admire the war fighter who gets all the television coverage and takes lethal risks. Then they come back wounded and America tends to say, ‘So, OK. We're sorry about that. But it's the war we're focused on.'